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Clinical Trial Summary

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.


Clinical Trial Description

Systemic therapy with pembrolizumab and eftilagimod alpha and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06128863
Study type Interventional
Source Maria Sklodowska-Curie National Research Institute of Oncology
Contact Katarzyna Kozak
Phone +48225462051
Email katarzyna.kozak@nio.gov.pl
Status Recruiting
Phase Phase 2
Start date July 17, 2023
Completion date April 30, 2027

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